Literature DB >> 27588746

Overcoming Challenges Facing Advanced Therapies in the EU Market.

Mohamed Abou-El-Enein1, Ahmed Elsanhoury2, Petra Reinke3.   

Abstract

While advanced therapy medicinal products offer great clinical promise, most EU-approved products have not achieved satisfactory commercial performance. Here we highlight a number of issues that prevent current products from obtaining commercial success and pitfalls that developers must overcome in future product development.
Copyright © 2016 Elsevier Inc. All rights reserved.

Mesh：

Year:  2016        PMID： 27588746     DOI： 10.1016/j.stem.2016.08.012

Source DB:  PubMed          Journal:  Cell Stem Cell        ISSN： 1875-9777            Impact factor:   24.633


  36 in total

Review 1.  Concise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions.

Authors:  Gerhard Bauer; Magdi Elsallab; Mohamed Abou-El-Enein
Journal:  Stem Cells Transl Med       Date:  2018-07-31       Impact factor: 6.940

Review 2.  New Models for the Evaluation of Specialized Medicinal Products: Beyond Conventional Health Technology Assessment and Pricing.

Authors:  Luca Pani; Karin Becker
Journal:  Clin Drug Investig       Date:  2021-05-20       Impact factor: 2.859

3.  Registry Contributions to Strengthen Cell and Gene Therapeutic Evidence.

Authors:  Mohamed Abou-El-Enein; David W Grainger; Sven Kili
Journal:  Mol Ther       Date:  2018-04-21       Impact factor: 11.454

Review 4.  Ocular stem cells: a narrative review of current clinical trials.

Authors:  Konstadinos Sotiropulos; Dimitrios Kourkoutas; Diamantis Almaliotis; Katherine Ploumidou; Vasileios Karampatakis
Journal:  Int J Ophthalmol       Date:  2022-09-18       Impact factor: 1.645

Review 5.  Scalable Manufacturing of CAR T cells for Cancer Immunotherapy.

Authors:  Mohamed Abou-El-Enein; Magdi Elsallab; Gerhard Bauer; Barbara Savoldo; Steven A Feldman; Andrew D Fesnak; Helen E Heslop; Peter Marks; Brian G Till
Journal:  Blood Cancer Discov       Date:  2021-08-03

6.  Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options.

Authors:  Rositsa Koleva-Kolarova; James Buchanan; Heleen Vellekoop; Simone Huygens; Matthijs Versteegh; Maureen Rutten-van Mölken; László Szilberhorn; Tamás Zelei; Balázs Nagy; Sarah Wordsworth; Apostolos Tsiachristas
Journal:  Appl Health Econ Health Policy       Date:  2022-04-04       Impact factor: 3.686

7.  Annuity payments can increase patient access to innovative cell and gene therapies under England's net budget impact test.

Authors:  Jesper Jørgensen; Panos Kefalas
Journal:  J Mark Access Health Policy       Date:  2017-07-31

Review 8.  Adaptation through Collaboration: Developing Novel Platforms to Advance the Delivery of Advanced Therapies to Patients.

Authors:  Magdalini Papadaki
Journal:  Front Med (Lausanne)       Date:  2017-05-29

Review 9.  The evolution of commercial drug delivery technologies.

Authors:  Ava M Vargason; Aaron C Anselmo; Samir Mitragotri
Journal:  Nat Biomed Eng       Date:  2021-04-01       Impact factor: 25.671

Review 10.  Unproven stem cell interventions: A global public health problem requiring global deliberation.

Authors:  Zubin Master; Kirstin R W Matthews; Mohamed Abou-El-Enein
Journal:  Stem Cell Reports       Date:  2021-06-08       Impact factor: 7.765
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